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临床试验/NCT05745324
NCT05745324已完成不适用

The Effect of Scaling and Root Planing on Gingival Crevicular Fluid and Salivary Levels of Inflammatory Biomarkers Among Electronic Nicotine Delivery Systems User, Smokers and Non-Smokers

Kuwait University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Clinical Attachment Level

研究概览

简要总结

Background/Aim: There are no studies that have compared the gingival crevicular fluid (GCF) levels of IL-1β in non-smokers (NS) and electronic nicotine delivery system (ENDS)-users before and after scaling and root planing (SRP) in patients with gingivitis. The aim of the present study is to compare the effect of scaling and root planing on the expression of IL-1β in the GCF among ENDS-users and NS clinically.

Methods: Self-reported current ENDS users and NS would be included. A questionnaire would be used to collect demographic data. All patients would undergo SRP. Clinical measures, periodontal parameters [probing depth (PD), plaque index (PI), and bleeding on probing (BOP)], and GCF IL-1β would be measured at baseline. At 1-week (T1) and 3 weeks (T2) of follow-up, periodontal parameters and GCF IL-1β levels would be re-assessed.

详细描述

2.1. Ethical approval Ethical approval was obtained from the Ethics Committee of Health Sciences Center at Kuwait University. All volunteering individuals were requested to read and sign a consent form written in simple English and Arabic.

2.2. Study Area/Setting The present longitudinal study was conducted between November 2021 and September 2022 at the Kuwait University Dental Center (KUDC). The study participants were regular patients attending the KUDC and the sampling design was convenience sampling.

2.3. Selection Criteria The inclusion criteria: ENDS-users, non-smokers, age (18-25), gender (men), periodontal health status (gingivitis), having minimum number of 20 teeth, and medically healthy. The exclusion criteria: Patients who did scaling and root planing in the past 3 months, T-cigs smokers, and dual smokers.

2.4. Data Collection Methods, Instrument Used, Measurements A standardized questionnaire including a consent form was used to gather information regarding gender, age (in years), nationality, marital status, highest level of education, oral hygiene status, last dental visit, last time that scaling and root planing was done, smoking status, type of smoked product, duration of ENDS usage (in years), frequency of ENDS usage per day, number of ENDS puffs taken per session, family smoking history, exposure to secondhand smoke, general health status, and attitude towards smoking.

2.5. Blinding

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

The investigators, care providers and outcome assessors would be blinded to the smoking status of the participants

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria: ENDS-users, cigarette smokers, non-smokers, age (18-60), gender (men), periodontal health status (gingivitis/periodontitis), having minimum number of 20 teeth, and medically healthy.

排除标准

  • The exclusion criteria: Patients who did scaling and root planing in the past 3 months.

结局指标

主要结局

Clinical Attachment Level

时间窗: 3 months

Level of gingival attachment would be assessed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jagan K Baskaradoss

Assistant Professor

Kuwait University

研究点 (2)

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